Recall Z-0081-2022— Philips North America LLC

Name: FDA recall Z-0081-2022
Creator: U.S. Food and Drug Administration
Published: 2021-02-09

Class II · Ongoing

Class II FDA medical device recall by Philips North America LLC, initiated 2021-02-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A. Reason: Customers were not notified of previous recalls associated with various defibrillator models..

Recalling firm: Philips North America LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-02-09
Firm location: Bothell, WA, United States

Product description

Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A

Reason for recall

Customers were not notified of previous recalls associated with various defibrillator models.

Data sourced from openFDA. This site is unofficial and independent of the FDA.